Dosage and administration
do not take more than directed adults and children 12 years of age and over Take 1-2 tablets every 4 hours as needed. Do not take more than 12 tablets in 24 hours children under 12 years of age Ask a doctor
Ephedrine Hydrochloride
- Manufacturer
- Walgreen Company
- Effective date
- 2023-12-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:04:26
Label at a glance#
ProductEphedrine Hydrochloride
Active ingredientEPHEDRINE HYDROCHLORIDE
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active ingredient (in each tablet)
Ephedrine Hydrochloride 12.5 mg
OTC - PURPOSE SECTION
Purpose
Bronchodilator
Use
for temporary relief of mild symptoms of intermittent asthma: wheezing tightness of chest shortness of breath
WARNINGS SECTION
Asthma alert: Because asthma may be life threatening, see a doctor if you
are not better in 60 minutes
get worse
need more than 12 tablets in 24 hours
use more than 8 tablets in 24 hours for 3 or more days a week
have more than 2 asthma attacks in a week
These may be signs that your asthma is getting worse.
This product will not give you asthma relief as quickly as an inhaled bronchodilator
OTC - DO NOT USE SECTION
Do not use
unless a doctor said you have asthma
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
if you have ever had an allergic reaction to this product or any of its ingredients
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
ever been hospitalized for asthma
heart disease
high blood pressure
diabetes
thyroid disease
seizures
narrow angle glaucoma
a psychiatric or emotional condition
trouble urinating due to an enlarged prostate gland
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions
taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)
OTC - WHEN USING SECTION
When using this product
your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may
cause death.
your risk of heart attack or stroke increases if you:
have a history of high blood pressure or heart disease
take this product more frequently or take more than the recommended dose
avoid foods or beverages that contain caffeine
avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect
OTC - STOP USE SECTION
Stop use and ask a doctor if
your asthma is getting worse (see Asthma alert)
you have difficulty sleeping
you have a rapid heart beat
you have tremors, nervousness, or seizure
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed
adults and children 12 years of age and over Take 1-2 tablets every 4 hours as needed. Do not take more than 12 tablets in 24 hours children under 12 years of age Ask a doctor
Other information
- store in a dry place at 15° – 30°C (59° – 86°F).
INACTIVE INGREDIENT SECTION
crospovidone, D&C yellow #10 lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid.
Questions or comments?
Call 1-800-925-4733
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF CARTON HAS BEEN OPENED OR BLISTER UNITS ARE TORN OR BROKEN
RETAIN THIS CARTON FOR COMPLETE PRODUCT INFORMATION
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
†Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands.
††This product is not manufactured or distributed by ARMSTRONG PHARMACEUTICALS, INC., owner of the registered trademark Primatene®.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Walgreens
NDC 0363-9812-07
Compare to the active ingredient in Primatene®††
Asthma Relief
EPHEDRINE HCl 12.5 mg / BRONCHODILATOR
• Relief of mild intermittent asthma symptoms
• Restores free breathing
60 Tablets
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| EPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d1bd959e-e326-44fb-b8ca-8c56a84a2a3d | Product name | 2 | 20251211 |
| f1d178e1-1663-4c63-ae37-62a1b322fba4 | Product name | 2 | 20251106 |
| f606d3ac-dd63-4b29-bea0-db23753b8ddc | Product name | 1 | 20220118 |
| 30254138-2d98-4aa2-8e07-ae82e8b0a389 | Product name | 3 | 20171103 |
| fee762de-ffd9-404d-8bc6-8c0c208e758d | Product name | 1 | 20170426 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-9812-07 | Ephedrine Hydrochloride | 15 in 1 BLISTER PACK | TABLET | 15 | 3 | |
| 0363-9812-07 | Ephedrine Hydrochloride | 4 in 1 CARTON | TABLET | 4 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Ephedrine Hydrochloride
- D&C YELLOW NO. 10 ALUMINUM LAKE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- SILICON DIOXIDE
- STEARIC ACID
- EPHEDRINE
- CROSPOVIDONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-9812 | 0363-9812-07 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| D&C YELLOW NO. 10 ALUMINUM LAKE | CQ3XH3DET6 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| EPHEDRINE HYDROCHLORIDE | NLJ6390P1Z | ACTIB |
| CROSPOVIDONE | 2S7830E561 | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ephedrine Hydrochloride | EPHEDRINE HYDROCHLORIDE | Walgreen Company | bcb81dc1-d854-30c0-e053-2a95a90a9fc7 | 2023-12-14 | Warnings | 0363-9812-07 0363-9812 00363981207 0c7a4c32-0af5-8e0d-e063-6294a90aebf7 bcb81dc1-d854-30c0-e053-2a95a90a9fc7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.